age greater than or equal to 60 years; informed consent; female; taiwan; japan; time
Item
male or female, age greater than or equal to 18 years (for japan and taiwan: age greater than or equal to 20 years) at the time of signing informed consent
boolean
C0001779 (UMLS CUI [1])
C0682069 (UMLS CUI [2])
type 1 diabetes mellitus; laboratory; screening; clinical; local; per
Item
type 1 diabetes mellitus (based on clinical judgement and/or supported by laboratory analysis as per local guidelines) 12 months or more prior to screening
boolean
C0011854 (UMLS CUI [1])
screening; insulin; regimen; visit
Item
currently treated with a basal-bolus insulin regimen for at least 12 months prior to screening (visit 1)
boolean
C0021641 (UMLS CUI [1])
screening; insulin; visit
Item
currently treated with a basal insulin analogue for at least 4 months prior to screening (visit 1)
boolean
C0650607 (UMLS CUI [1])
laboratory; hba1c; both
Item
hba1c 7.0-9.5% (53-80 mmol/mol) (both inclusive) as assessed by central laboratory
boolean
C0019018 (UMLS CUI [1])
body mass index
Item
body mass index less than or equal to 35.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
myocardial infarction; unstable angina; hospitalization; stroke
Item
within the past 180 days any of the following: myocardial infarction, stroke or hospitalization for unstable angina and/or transient ischemic attack
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
C0038454 (UMLS CUI [4])
new york heart association classification; class iv; planned
Item
subjects presently classified as being in new york heart association (nyha) class iv currently planned coronary, carotid or peripheral artery revascularisation
boolean
C1882087 (UMLS CUI [1])
C3203629 (UMLS CUI [2])
ketoacidosis; screening; diabetic; visit; last
Item
diabetic ketoacidosis requiring hospitalisation within the last 180 days prior to screening (visit 1)
boolean
C0011880 (UMLS CUI [1])